Label: ADULT GLYCERIN LAXATIVE - glycerin suppository
- NDC Code(s): 49781-081-25
- Packager: Cardinal Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Drug Facts Active ingredient
Glycerin, USP 2 gClose
- Keep out of reach of children.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).Close
For relief of occasional constipationClose
For rectal use only. May cause rectal discomfort or burning sensation.Close
- Ask a doctor before use if you have
- abdominal pain, nausea or vomiting.
- a sudden change in bowel habits lasting for more than 2 weeks.
- already used a laxative for more than 1 week.
- Stop use and ask a doctor
if you have rectal bleeding or fail to have a bowel movement after using a laxative.Close
This may indicate a serious condition.
- If pregnant or breastfeeding,
ask a doctor before use.Close
Single Daily dosage: 1 suppository or as directed by a doctor
- Adults and children 6 years and over:
- detach 1 suppository from the strip; remove the wrapper before inserting into the rectum as follows:
- hold suppository with pointed end up
- carefully separate tabs with fingernail
- slowly pull apart by pulling tabs down on both sides
- remove suppository from wrapper
- insert one suppository well up into the rectum
- children 2 to 6 years use Leader Pediatric Glycerin Suppositories
- children under 2 years of age ask a doctor
- Inactive ingredients
sodium stearate, purified waterClose
- Other information
- This product usually produces a bowel movement in 1/4 to 1 hour
- Store container tightly closed
- Keep from excessive heat
- Adult Glycerin Suppositories Label
Compare to Fleet® active ingredient*
25 Adult Size
TAMPER-EVIDENT FOR YOUR SAFETY, SUPPOSITORIES ARE PACKED IN TAMPER-EVIDENT SEALED WRAPPER. DO NOT USE IF WRAPPER IS TORN OR OPEN
E-Z Open Wrapper
Distributed by Cardinal Health, Inc.
Dublin, OH 43017 CIN # 4866216
ALL LEADER® Brand Products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
This product is not manufactured or distributed by C.B. Fleet Co. Inc., owner of the registered trademark Fleet®
- INGREDIENTS AND APPEARANCE
ADULT GLYCERIN LAXATIVE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-081 Route of Administration RECTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2 g Inactive Ingredients Ingredient Name Strength SODIUM STEARATE (UNII: QU7E2XA9TG) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-081-25 25 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/01/2014 Labeler - Cardinal Health, Inc. (097537435) Registrant - Acino Products LLC (019385518) Establishment Name Address ID/FEI Business Operations Acino Products LLC 019385518 manufacture(49781-081)